JP2009515658A5 - - Google Patents

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JP2009515658A5
JP2009515658A5 JP2008541327A JP2008541327A JP2009515658A5 JP 2009515658 A5 JP2009515658 A5 JP 2009515658A5 JP 2008541327 A JP2008541327 A JP 2008541327A JP 2008541327 A JP2008541327 A JP 2008541327A JP 2009515658 A5 JP2009515658 A5 JP 2009515658A5
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balloon
heart valve
prosthetic heart
deflection
distal end
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JP5095625B2 (en
JP2009515658A (en
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Priority claimed from US11/280,063 external-priority patent/US8764820B2/en
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Claims (21)

患者の大動脈弁輪に人工心臓弁を移植するオフポンプ低侵襲手術システムであって、
その遠位端のバルーンと該バルーンの近位端を係合する遠位スリーブを有する可動プッシャとを含むバルーンカテーテルと、
該バルーンカテーテルの該遠位端のバルーンの上に装着されたバルーン拡張可能人工心臓弁と、
を備え、該患者の心臓が鼓動している間に、
該患者の左心室の心尖部またはその近傍の心室壁を通って穿刺が生成され、
該穿刺を通ってイントロデューサーシースが挿入され、
該イントロデューサーシースを通って該左心室に該バルーンカテーテルが通過し、
該プッシャおよびスリーブが、該人工心臓弁を該大動脈弁輪内に配置できるように、該バルーンおよびその上に装着された該人工心臓弁を前進させるために使用され、
該プッシャおよびスリーブが、該バルーンに対して近位に移動し、
該大動脈弁輪における該人工心臓弁を拡張させるために該バルーンが膨張する、システム。 An off-pump minimally invasive surgical system for implanting an artificial heart valve into a patient's aortic annulus ,
A balloon catheter comprising a movable pusher having a distal sleeve that engages the proximal end of the distal end of the balloon and the balloon,
A balloon expandable prosthetic heart valve mounted on a balloon of the distal end of the balloon catheter,
And while the patient's heart is beating,
A puncture is generated through the ventricular wall at or near the apex of the patient's left ventricle ,
An introducer sheath is inserted through the puncture,
The balloon catheter is passed into the left ventricle through the introducer sheath,
The pusher and sleeve are used to advance the balloon and the prosthetic heart valve mounted thereon so that the prosthetic heart valve can be placed in the aortic annulus;
The pusher and sleeve move proximally relative to the balloon ;
The system , wherein the balloon is inflated to expand the prosthetic heart valve in the aortic annulus. 巾着縫合の第１の糸が、概して、前記患者の前記左心室の心尖部または近傍の周囲を画定する一方向の第１の円に配置され、その後、巾着縫合の第２の糸が、概して、該第１の円と同心の円であるが反対方向に配置され、
該周囲の範囲内に穿刺が生成され、
該穿刺を通って前記イントロデューサーシースが挿入された後、その周囲に密封を生成するために該巾着縫合が締着される、請求項１に記載のシステム。 A first thread of a purse string suture is generally disposed in a first unidirectional circle that defines a perimeter of or near the apex of the left ventricle of the patient, after which a second thread of the purse string suture is generally , Arranged concentrically with the first circle but in the opposite direction ;
A puncture is generated within the surrounding area ,
After the introducer sheath through the puncture has been inserted,該巾attachment sutures are fastened to generate a seal around, the system according to claim 1. 前記バルーンカテーテルはその中に操縦機構を含み、
該バルーンカテーテルは、前記大動脈弁輪内に前記人工心臓弁を配置することを容易にするように、前記左心室内の該操縦機構を用いて操縦される、請求項１に記載のシステム。 The balloon catheter includes a steering mechanism therein,
The system of claim 1, wherein the balloon catheter is steered using the steering mechanism in the left ventricle to facilitate placement of the prosthetic heart valve within the aortic annulus. 前記バルーンカテーテルは、前記バルーンの直近位に位置する偏向セグメントを含み、
その上に装着された該バルーンおよび人工心臓弁に角度を付けるために、該偏向セグメントが屈曲される、請求項３に記載のシステム。 The balloon catheter includes a deflection segment located proximally of the balloon ;
4. The system of claim 3, wherein the deflection segment is bent to angle the balloon and prosthetic heart valve mounted thereon. 前記プッシャスリーブは前記偏向セグメントの上に載っており、
前記バルーンが膨張する前に、前記プッシャおよびスリーブが、該偏向セグメントに対して近位に移動する、請求項４に記載のシステム。 The pusher sleeve rests on the deflection segment;
Before the balloon is inflated, the pusher and sleeve are moved proximally relative to the deflecting segment, system of claim 4. 前記偏向セグメントが屈曲される前に、前記プッシャおよびスリーブが、該偏向セグメントに対して近位に移動する、請求項５に記載のシステム。 Before the deflecting segment is bent, the pusher and sleeve are moved proximally relative to the deflecting segment, system according to claim 5. 自然大動脈弁尖が適切な位置に置かれた状態にすることにより、前記バルーンを膨張させることにより前記人工心臓弁がそれと接触する、請求項１に記載のシステム。 The system of claim 1, wherein the prosthetic heart valve is in contact with it by inflating the balloon by placing a natural aortic valve leaflet in place . 前記人工心臓弁は、前記大動脈弁輪に以前に移植された人工心臓弁と接触するように拡張される、請求項１に記載のシステム。 The prosthetic heart valve is expanded to contact the aortic annulus to the previously implanted prosthetic heart valve system of claim 1. 人工心臓弁を患者の大動脈弁輪に送達するオフポンプ低侵襲手術システムであって、
拡張状態で提供される拡張可能な人工心臓弁と、
遠位端を有する送達カテーテルと、
を備え、該患者の心臓が鼓動している間に、
該拡張可能な人工心臓弁が、該送達カテーテル遠位端の上で収縮状態まで圧着され、
肋間のアクセス開口部が作成されて、該患者の左心室の心尖部が露呈され、
該左心室の心尖部または近傍で穿刺が生成され、
該穿刺を通ってイントロデューサーシースが挿入され、
該イントロデューサーシースを通って該左心室に該送達カテーテルが通過し、
該人工心臓弁が該大動脈弁輪内に適切に配置および配向されるように、該送達カテーテルの遠位端が前進および操縦され、
該大動脈弁輪において、それと接触するように該人工心臓弁が拡張される、システム。 An off-pump minimally invasive surgical system for delivering a prosthetic heart valve to a patient's aortic annulus ,
A prosthetic heart valve that can be expanded to be provided in an expanded state,
A delivery catheter having a distal end,
And while the patient's heart is beating,
The expandable prosthetic heart valve is crimped onto the delivery catheter distal end to a contracted state ;
Access opening of the intercostal has been created, the apex of the left ventricle of the patient is exposed,
A puncture is generated at or near the apex of the left ventricle ,
An introducer sheath is inserted through the puncture ,
Passing the said delivery catheter into the left ventricle through the introducer sheath,
The distal end of the delivery catheter is advanced and steered so that the prosthetic heart valve is properly positioned and oriented within the aortic annulus ,
And has it the aorta annulus therewith the artificial heart valve into contact is extended, the system. 前記送達カテーテルはその遠位端にバルーンを含み、前記人工心臓弁はバルーン拡張可能ステントを含み、前記大動脈弁輪と接触するように人工心臓弁を外側へ拡張させるために、該バルーン内に液体が注入される、請求項９に記載のシステム。 Wherein the delivery catheter includes a balloon at its distal end, the prosthetic heart valve includes a balloon expandable stent, in order to expand the prosthetic heart valve outward into contact with the aortic annulus, the liquid in the balloon 10. The system of claim 9 , wherein is injected. 自然大動脈弁尖が適切な位置に置かれる状態にすることにより、前記バルーンを膨張させることによって前記人工心臓弁がそれと接触する、請求項９に記載のシステム。 By the state of leaflets native aortic valve is placed in position, the artificial heart valve is in contact with it by inflating the balloon system according to claim 9. 前記送達カテーテルは、その遠位端の直近位に位置する偏向セグメントを含み、
偏向セグメントが屈曲されることにより、その上の遠位端に装着された前記人工心臓弁の角度を付ける、請求項９に記載のシステム。 The delivery catheter includes a deflection segment located immediately proximal to its distal end ;
The Rukoto deflection segments is bent, angled in the artificial heart valve mounted to the distal end thereon, the system of claim 9. 前記送達カテーテルは、前記偏向セグメントの上に装着された遠位スリーブを有するプッシャをさらに含み、
該送達カテーテルの遠位端およびその上に装着された人工心臓弁を前進させるために、該プッシャおよびスリーブが使用され、
該プッシャおよびスリーブが、該偏向セグメントが屈曲される前に、該偏向セグメントに対して近位に移動する、請求項１２に記載のシステム。 The delivery catheter further includes a pusher having a distal sleeve mounted over the deflection segment;
The pusher and sleeve are used to advance the distal end of the delivery catheter and the prosthetic heart valve mounted thereon,
The pusher and sleeve, before said deflection segments are bent to move proximally with respect to the deflecting segment, system of claim 12. ２４フレンチ以下の自身を通過する管腔を有するイントロデューサーシースと、
遠位端の上にバルーンを有するバルーンカテーテルであって、該遠位端を偏向させるための操縦機構をさらに含む、バルーンカテーテルと、
該バルーンの上に圧着されたバルーン拡張可能な人工心臓弁と
を含み、
自身の上に該人工心臓弁を有する該バルーンカテーテルの外側寸法は、該イントロデューサーシース管腔を通過するのに十分に小さい、低侵襲人工心臓弁送達システム。 An introducer sheath having a lumen passing through itself of no more than 24 French;
A balloon catheter having a balloon on the distal end, further comprising a steering mechanism for deflecting the distal end;
A balloon expandable prosthetic heart valve crimped onto the balloon;
A minimally invasive prosthetic heart valve delivery system, wherein the outer dimensions of the balloon catheter having the prosthetic heart valve thereon are sufficiently small to pass through the introducer sheath lumen. 前記操縦機構は、前記バルーンの直近位に位置する前記バルーンカテーテルの上の偏向セグメントを含む、請求項１４に記載のシステム。   15. The system of claim 14, wherein the steering mechanism includes a deflection segment on the balloon catheter that is located immediately proximal to the balloon. 前記偏向セグメントの遠位端に接続され、前記バルーンカテーテルを通って近位の偏向ハンドルまで延在する偏向ワイヤをさらに含む、請求項１５に記載のシステム。   The system of claim 15, further comprising a deflection wire connected to a distal end of the deflection segment and extending through the balloon catheter to a proximal deflection handle. 前記偏向セグメントおよび前記バルーンの近位端を包囲するような大きさにされた遠位スリーブを有するプッシャであって、該プッシャは該偏向セグメントに対して縦方向に移動可能である、プッシャをさらに含む、請求項１５に記載のシステム。   A pusher having a distal sleeve sized to surround the deflection segment and the proximal end of the balloon, the pusher further movable in a longitudinal direction relative to the deflection segment; 16. The system of claim 15, comprising. 前記バルーンカテーテルは、
前記バルーンの反対端に接続され、該バルーンを同心円状で交互に伸張および短縮させるように互いに摺動可能に配置される内側および外側バルーン膨張管と、
該内側バルーン膨張管を移動させるための内側管ハンドルと、
該内側バルーン膨張管が通過し、該外側バルーン膨張管が接続するバルーン膨張コネクタと、
該バルーン膨張コネクタ内で画定される空間への側面ポート開口部であって、該側面ポートは、前記空間へ、および該バルーンを膨張させるための該内側および外側バルーン膨張管の間の管状空間へ膨張流体を導入するために適合される、側面ポート開口部と
をさらに含む、請求項１４に記載のシステム。 The balloon catheter is
An inner and outer balloon inflation tube connected to opposite ends of the balloon and slidably arranged relative to each other so as to alternately expand and contract the balloon concentrically;
An inner tube handle for moving the inner balloon inflation tube;
A balloon inflation connector through which the inner balloon inflation tube passes and to which the outer balloon inflation tube connects;
A side port opening to a space defined within the balloon inflation connector, wherein the side port is into the space and into a tubular space between the inner and outer balloon inflation tubes for inflating the balloon. The system of claim 14, further comprising: a side port opening adapted to introduce inflation fluid. 前記バルーン膨張コネクタの直遠位に接続され、前記外側バルーン膨張管が通過する偏向ハンドルであって、該外側バルーン膨張管は、前記内側バルーン膨張管の通路のための第１の管腔と第２の管腔とを含む、偏向ハンドルと、
偏向ハンドルの上のアクチュエータに接続され、該外側バルーン膨張管の該第２の管腔を通って前記バルーンカテーテルの遠位端に入る偏向ワイヤと、
をさらに含む、請求項１８に記載のシステム。 A deflection handle connected directly distal to the balloon inflation connector and through which the outer balloon inflation tube passes, the outer balloon inflation tube having a first lumen and a first lumen for a passage of the inner balloon inflation tube A deflection handle including two lumens;
A deflection wire connected to an actuator on a deflection handle and entering the distal end of the balloon catheter through the second lumen of the outer balloon inflation tube;
The system of claim 18, further comprising: 前記バルーンカテーテルは、約２４インチ以下（６１ｃｍ）の前記イントロデューサにはめ込むような大きさにされた作業長さを有する、請求項１４に記載のシステム。   15. The system of claim 14, wherein the balloon catheter has a working length sized to fit within the introducer of about 24 inches or less (61 cm). 前記イントロデューサは、約１３インチ（３３ｃｍ）以下の全長を有する、請求項２０に記載のシステム。   21. The system of claim 20, wherein the introducer has a total length of about 13 inches (33 cm) or less.
JP2008541327A 2005-11-16 2006-11-15 Transapical heart valve delivery system Active JP5095625B2 (en)

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US11/280,063 US8764820B2 (en) 2005-11-16 2005-11-16 Transapical heart valve delivery system and method
US11/280,063 2005-11-16
PCT/US2006/044422 WO2007059252A1 (en) 2005-11-16 2006-11-15 Transapical heart valve delivery system and method

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JP2009515658A5 true JP2009515658A5 (en) 2010-12-09
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